REFLECTION CERAMIC ACETABULAR SYSTEM
FDA premarket approval P030022/S040 · decided 2016-11-09
Approval details
- PMA number
- P030022
- Supplement
- S040
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2016-10-17
- Decision date
- 2016-11-09
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the addition of an inspection step to the R3 Shells.
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